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ACTIVE NOT RECRUITING Phase 2

Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer

NCT01898494 · View on ClinicalTrials.gov ↗

Study Summary

This randomized phase II trial studies how well transoral surgery followed by low-dose or standard-dose radiation therapy works in treating patients with human papilloma virus (HPV) positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet known how much extra treatment needs to be given after surgery.

Interventions

  • DRUG cisplatin
  • DRUG carboplatin
  • RADIATION intensity-modulated radiation therapy
  • PROCEDURE Transoral surgery

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center — Duarte
  • UCLA / Jonsson Comprehensive Cancer Center — Los Angeles
  • Kaiser Permanente Oakland-Broadway — Oakland
  • Stanford Cancer Institute — Palo Alto
  • UCSF Medical Center-Mount Zion — San Francisco

Colorado

  • Rocky Mountain Cancer Centers-Boulder — Boulder
  • Penrose-Saint Francis Healthcare — Colorado Springs
  • Rocky Mountain Cancer Centers-Penrose — Colorado Springs
  • Porter Adventist Hospital — Denver

Florida

  • University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
  • Florida Hospital Orlando — Orlando

Georgia

  • Emory University Hospital Midtown — Atlanta
  • Emory University/Winship Cancer Institute — Atlanta

Alabama

  • University of Alabama at Birmingham Cancer Center — Birmingham

Arizona

  • Mayo Clinic in Arizona — Scottsdale

Arkansas

  • University of Arkansas for Medical Sciences — Little Rock

Connecticut

  • Yale University — New Haven

Trial Details

FieldValue
Enrollment Target 519 participants
Start Date 2014-01-22
Est. Completion 2026-12
Phase Phase 2

Sponsor

ECOG-ACRIN Cancer Research Group

52 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01898494

The ClinicalTrials.gov registry entry for NCT01898494 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 519 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Human Papilloma Virus Infection appearing as the primary indexed condition, and to 4 interventions — of which cisplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01898494 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01898494 about?

NCT01898494 is a clinical study titled "Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer". This randomized phase II trial studies how well transoral surgery followed by low-dose or standard-dose radiation therapy works in treating patients with human papilloma virus (HPV) positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used...

What is the current status of trial NCT01898494?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 519 participants. The study started on 2014-01-22. Estimated completion is 2026-12.

What conditions does trial NCT01898494 study?

This clinical trial studies the following conditions: Human Papilloma Virus Infection, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Oropharynx. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01898494?

The interventions under investigation include: cisplatin (DRUG), carboplatin (DRUG), intensity-modulated radiation therapy (RADIATION), Transoral surgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01898494?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01898494 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial